CN105873633B - Connection device for medical equipment - Google Patents

Abstract

A kind of attachment device for Medical Devices, including the first connector having a first end and a second end, first connector defines at least one channel close to the first end.At least one described channel has axially extending first, and the shoulder of the first end close to first connector, the shoulder define feeder connection.At least one described channel has second extended in the axial transverse direction.The attachment device further includes the second connector having a first end and a second end, and close at least one protrusion of the first end.The shoulder is used at least one protrusion of the second connector importing the feeder connection, without considering at least one the described positioning of protrusion relative to the feeder connection.

Description

Connection device for medical equipment

technical field

The present application relates to a connection device for medical equipment. More specifically, the present application relates to a connector for a closed system transfer device (CSTD), including a connector capable of interengaging and locking two connectors of the CSTD.

Background technique

The treatment of many conditions, disorders and diseases involves the use of toxic drugs. For example, the treatment of some kidney diseases often involves the use of cyclophosphamide, an alkylating agent. The side effects of cyclophosphamide therapy are well known and expected by patients receiving such therapy, but healthcare workers using cyclophosphamide also face exposure risks during the formulation and subsequent administration to patients.

Devices exist in the prior art for the formulation and subsequent use of toxic drugs, commonly referred to as closed system transfer devices (CSTDs). Typically, these devices include adapters for connecting vials containing powdered or lyophilized drugs, adapters on syringes, and adapters on catheters that provide fluid access to a patient's circulatory system. Typically, healthcare workers connect the syringe to the bottle by attaching their respective adapters to reconstitute powdered or lyophilized medication with saline or other formulation medium, dispense the medication, draw the medication into the syringe, detach the adapter, and then Connect the syringe to the fluid conduit via the respective adapter for use by the patient.

A typical CSTD inherently requires various adapters to be attached or detached in order to formulate and administer the drug. This repeated connection and disconnection increases the risk of accidents and exposure to toxic drugs. Professional organizations and government agencies alike have identified safety concerns with the use of these medicines as critical.

SUMMARY OF THE INVENTION

In one aspect, a connecting device for a medical device includes a first connecting member having a first end and a second end, the first connecting member having at least one channel opened near the first end. The at least one channel has an axially extending first portion, the at least one channel has a shoulder proximate the first end of the first connector, the shoulder defining a channel inlet. The at least one channel has a second portion extending in a direction transverse to the axial direction. The connecting device further includes a second connecting piece having a first end and a second end, the second connecting piece being provided with at least one protrusion near the first end. When the at least one projection of the second link enters the at least one channel of the first link, axial movement of the second link relative to the first link causes the At least one of the first connector and the second connector is rotated relative to the other connector into a locked state, wherein the shoulder is used to guide the at least one protrusion of the second connector into the locked state. the channel entrance without regard to the positioning of the at least one protrusion relative to the channel entrance.

The channel inlet is wider than the first portion of the at least one channel and the second portion of the at least one channel. The second portion of the at least one channel includes an axially extending groove. The groove extends along the first end of the first connector. In other examples, the groove extends along the second end of the first connector relative to the second portion of the at least one channel. When the first connecting piece and the second connecting piece are in the locked state, the at least one protrusion and the groove form a positive locking to movably fix the first connecting piece and the second connecting piece . The second portion of the at least one channel includes a generally axial groove extending distally of the first end of the first connector and toward the first end of the first connector The proximally extending generally axial groove.

The first connector and the second connector also include a fluid passage therethrough, the fluid channel forming a fluid path when the first connector and the second connector are engaged. At least one of the first connector and the second connector further includes a self-healing membrane within the respective liquid channel, the self-healing membrane when the first connector is engaged with the second connector The membrane forms a watertight seal. The connecting device further includes an indicator for indicating a locked state between the first connecting member and the second connecting member. The indicator is a visual indicator. In one example, the first connector and the second connector include a flat portion and an arcuate portion, respectively, and the visual indicator is determined by the alignment of the flat portion of the first connector with the flat portion of the second connector, and The arc-shaped portion of the first connector is formed by aligning the arc-shaped portion of the second connector. In other examples, the indicator is a tactile indicator, eg, the interaction of the at least one protrusion and groove provides a tactile indication of the locked state.

The first end of the second connector includes a sidewall surrounding the hollow, the sidewall extending axially away from the second end of the second connector, wherein the sidewall includes the at least One protrusion, the at least one protrusion extending inwardly. One of the first connector and the second connector is provided on the syringe adapter and the other is provided on at least one of the bottle adapter and the patient connector. The shoulder is rounded and the first portion of the at least one channel defines a non-linear path.

In another aspect, a connecting device for a medical device includes a first connecting member having a first end and a second end, the first connecting member having at least one channel opened near the first end. The at least one channel has a first portion extending from a location proximate the first end of the first connector to the second end of the first connector. The at least one channel has a shoulder proximate the first end of the first connector, the shoulder defining a channel inlet, the at least one channel having a second portion extending from the first portion . The connecting device further includes a second connecting piece having a first end and a second end, the second connecting piece being provided with at least one protrusion near the first end. The at least one protrusion of the second connector is used to enter the at least one channel of the first connector. The first connector and the second connector have a locked state in which the first connector and the second connector are fixed. When the first connecting member and the second connecting member are in the locked state, the at least one protrusion of the second connecting member is located at the second portion of the at least one channel of the first connecting member portion, wherein the channel inlet is wider than the first portion of the at least one channel of the first connector.

The first portion of the at least one channel of the first connector is non-linear. The second portion of the at least one channel of the first connector extends in a direction transverse to the longitudinal axis of the first connector. The second portion of the at least one channel includes an axially extending groove.

Description of drawings

1 is an exploded schematic view of a liquid closed transfer system provided by an embodiment of the present invention, showing a syringe adapter, a bottle adapter and a patient connector;

FIG. 2 is a front view of the patient connector shown in FIG. 1 according to an embodiment of the present invention;

3 is a side view of the patient connector shown in FIG. 1 provided by an embodiment of the present invention;

4 is a schematic bottom view of the patient connector shown in FIG. 1 according to an embodiment of the present invention;

FIG. 5 is a schematic top-view structural diagram of the patient connector shown in FIG. 1 according to an embodiment of the present invention;

6 is a cross-sectional view of the patient connector shown in FIG. 1 according to an embodiment of the present invention;

FIG. 7A is a front view of the connector of the patient connector shown in FIG. 1 according to another embodiment of the present invention;

FIG. 7B is a front view of the connector of the patient connector shown in FIG. 1 according to still another embodiment of the present invention;

8 is a front view of the syringe adapter shown in FIG. 1 provided by an embodiment of the present invention;

9 is a side view of the syringe adapter shown in FIG. 1 provided by an embodiment of the present invention;

10 is a schematic top view of the syringe adapter shown in FIG. 1 according to an embodiment of the present invention;

11 is a schematic bottom view of the syringe adapter shown in FIG. 1 according to an embodiment of the present invention;

12 is a cross-sectional view of a connector of the syringe adapter shown in FIG. 1 provided by an embodiment of the present invention;

13 is a front view of the bottle adapter shown in FIG. 1 provided by an embodiment of the present invention;

Figure 14 is a side view of the bottle adapter shown in Figure 1 provided by an embodiment of the present invention;

15 is a schematic bottom view of the bottle adapter shown in FIG. 1 according to an embodiment of the present invention;

16 is a schematic top view of the bottle adapter shown in FIG. 1 according to an embodiment of the present invention;

17 is a cross-sectional view of the bottle adapter shown in FIG. 1 provided by an embodiment of the present invention;

FIG. 18 is a schematic structural diagram of the syringe adapter and the patient connector shown in FIG. 1 during the connection process according to an embodiment of the present invention;

19 is a schematic structural diagram of the syringe adapter and the patient connector shown in FIG. 1 in a connected state according to an embodiment of the present invention;

20 is a cross-sectional view of the syringe adapter and the patient connector shown in FIG. 1 in a connected state according to an embodiment of the present invention;

21 is a front view of the syringe adapter and the bottle adapter shown in FIG. 1 in a connected state according to an embodiment of the present invention;

22 is a schematic structural diagram of a bottle adapter provided by the second embodiment of the present invention;

Fig. 23 is a front view of the syringe adapter provided by the second embodiment of the present invention, showing the syringe adapter connected with the bottle adapter shown in Fig. 22;

Figure 24 is a schematic bottom view of the syringe adapter shown in Figure 22 and the bottle adapter shown in Figure 22, showing the syringe adapter connected to the bottle adapter;

Figure 25 is a cross-sectional view of the syringe adapter shown in Figure 22 and the bottle adapter shown in Figure 22, showing the syringe adapter connected to the bottle adapter;

26A-26E are partial front cross-sectional views of other embodiments of projections of the second connector.

Detailed ways

For the purpose of the following description, the terms "upper", "lower", "right side", "left side", "vertical", "horizontal", "top", "bottom", "horizontal" "longitudinal", "longitudinal" and their derivatives shall be relative to the orientation in which the invention is presented in the drawings. Of course, it should be understood that, unless expressly stated otherwise, the present invention is capable of various alternative modifications. It is also to be understood that the specific apparatuses depicted in the drawings and described in the following specification are merely exemplary embodiments of the present invention.

As shown in FIG. 1 , a non-limiting example of a system 1 for closed transfer of liquid between a first container and a second container (not shown) includes a syringe adapter 2 , a bottle adapter 4 and a patient connector 6 . The bottle adapter 4 and the patient connector 6 include a first connection 10 and the syringe adapter 2 includes a second connection 70 . Although FIG. 1 shows the bottle adapter 4 and the patient connector 6 with the first connector 10 and the syringe adapter 2 with the second connector 70, it will be understood by those skilled in the art that the first connector 10 and the The second connector 70 can be independently associated with any medical device. Additionally, the first connector 10 may be associated with the syringe adapter 2 and the second connector 70 may be associated with the bottle adapter 4 and the patient connector 6 . Additionally, although not shown, the first connector 10 may be provided on an IV bag adapter or any other device commonly used in CSTD systems. Accordingly, the examples shown in the following figures should be considered as illustrative, non-limiting examples only.

As shown in FIGS. 1-7B and 13-17 , a non-limiting embodiment of the present invention provides a first connector 10 including a first end 20 and a second end 25 . The first end 20 can be a three-dimensional structure, and the second end 25 can be any structure, such as but not limited to a gripping surface, an adaptor for the CSTD, a connector for determining another connector or other part of the CSTD visual indicators of tight engagement or any valid combination thereof. The first connector 10 may be made of any suitable material, such as, but not limited to, plastic and medical grade polymers. These polymers are available under the trademarks of DuPont as well as The product. In a non-limiting example, the second end 25 is a special adapter, and the first connector 10 may be made of any suitable material, wherein the first end 20 is made of plastic or medical grade polymer or other suitable material.

Further as shown in FIGS. 1-7B and 13-17 , in a non-limiting embodiment of the present invention, the first connecting member 10 is opened from a part of the first end 20 away from the second end 25 toward the second end At least one channel 30 extends from a portion of the first end 20 of 25 . The channel 30 is used in the process of engaging the first connector 10 with the second connector 70 (shown in Figures 8-12), and the channel 30 may follow any available path. In a non-limiting example, the channel 30 follows a non-linear path, such as a substantially curved path as shown in Figures 1-7B and 13-17, although the channel 30 may also have a rectilinear path or be composed of many rectilinear sections path.

The channel 30 may have a number of discrete portions including the channel inlet 50 , an axial or substantially axial portion 35 extending along the length of the first end 20 of the first connector 10 and extending transversely to the axial portion 35 The transverse portion 60 near the second end 25. The first end 20 of the first connector 10 containing the channel inlet 50 also includes a shoulder 40 that defines the channel inlet 50 . In a non-limiting example, shoulder 40 is rounded to direct objects that contact shoulder 40 into channel inlet 50 . The rounded nature of the shoulder 40 allows the first connector 10 and the second connector 70 (shown in FIGS. 8-12 ) to cooperate with each other without any pre-positioning of the components, reducing the difficulty of achieving a fixed connection. In addition to providing a rounded shoulder 40, the shoulder 40 may have a peak or any other suitable shape to guide the second connector 70 into the channel inlet 50, regardless of the positioning of the engagement members relative to each other.

In a non-limiting example, the transverse portion 60 of the channel 30 is substantially perpendicular to the axial portion 35 of the channel 30 . In a non-limiting example, the channel inlet 50 is preferably wider than the remaining portions 35, 60 of the channel 30, reducing the difficulty of engaging the first connector 10 with the second connector 70, as will be described below. In a non-limiting example, the channel 30 includes at least one groove 100 at the terminus of the transverse portion 60 . In a non-limiting example, the groove 100 extends axially along the second end 25 of the first connector 10 , either away from or near the second end 25 of the first connector 10 .

In the non-limiting example shown in Figure 7A, at the end of the transverse portion 60 of the channel 30, a plurality of grooves are provided. In a non-limiting example, the groove 110 extends away from the second end of the connector and the groove 120 extends in a direction super-proximal to the second end of the connector. Under this structure, there are many ways to fix the protrusions 90 of the second connecting piece, so that the first connecting piece and the second connecting piece are fixed by the engaging structure. Those skilled in the art will appreciate the variety of such structures, such as springs and other flexible and resilient devices and devices, so long as the protrusions 90 are retained in the grooves 110 and/or 120 . The grooves 110, 120 are provided with protrusions or structures capable of providing a tactile and audible indication when the device is in the locked state. The protrusion 90 can only be held in the locked position by the cooperation between the protrusion 90 and the structure defining the grooves 110, 120, and cannot be used to connect the offset. Specifically, the projection 90 and the grooves 110 , 120 may be used to maintain the locked position within the transverse portion 60 until sufficient rotational force is applied to cause the projection 90 to clear the grooves 110 , 120 .

In the non-limiting example shown in FIG. 7B , a groove is provided at the end of the transverse portion 60 of the channel 30 . In a non-limiting example, the groove 110 extends in a direction away from the second end of the connector. As described above, the grooves 110 may form protrusions and provide tactile and audible indications when the device is in the locked state. The protrusion 90 can only be held in the locked position by the cooperation between the protrusion 90 and the structure defining the grooves 110, 120, and cannot be used to connect the offset. Specifically, the projection 90 and the grooves 110 , 120 may be used to maintain the locked position within the transverse portion 60 until sufficient rotational force is applied to cause the projection 90 to clear the grooves 110 , 120 .

As shown in FIGS. 2-6 , the first connector 10 is connected to the patient connector 6 . The patient connector 6 has a fluid channel 130 opened therethrough. The second end 25 further includes a surface 26 capable of tightly engaging the second connector 70 . The surface 26 may be flat or any other configuration as long as the first connector 10 and the second connector 70 are in close contact. The surface 26 of the first connector 10 may also include elastic or flexible members that facilitate the connection and separation of the first connector 10 and the second connector 70 with each other. The patient connector 6 also includes a male or female luer lock 122 for connecting the patient connector 6 to a fluid conduit for fluid communication with the patient's circulatory system, eg, an intravenous line.

As shown in FIG. 6 , the liquid channel 130 passes through the patient connector 6 and the first connector 10 for liquid communication with the corresponding liquid channel of the second connector 70 , so that when the first connector 10 and the second connector When 70 are engaged, a fluid path is formed therein. The fluid passage 130 and/or the first and second ends 20 and 25 of the first connector 10 may include a seal or diaphragm in any preferred location to assist in forming when the first connector 10 and the second connector 70 are engaged Watertight seal. Those skilled in the art are familiar with these seals and membranes, which may include self-healing seals and membranes, and should be selected based on the intended use of the device, such as biocompatibility, chemical inertness, and compatibility with any Compatibility of chemical agents or treatments, FDA and/or OSHA approved and for CSTD. These seals can be made of natural materials (eg rubber), synthetic polymers and/or silicones (eg RTV silicone). Specifically, the proximal end of the first end 20 of the connector may include a septum for forming a seal when mated with the corresponding component of the second connector 70 .

As shown in FIGS. 8-12 , the syringe adapter 2 includes a second connector 70 for cooperating with the first connector 10 . The second connector 70 includes a first end 80 and a second end 85 . The second connector 70 may be made of any suitable material. For example and without limitation, the second connector 70 may be made of plastic or a medical grade polymer. In a non-limiting example, the second connector 70 is made of the same material as the first connector 10 or the first end 20 of the first connector 10 . The first end 80 further includes a surface 81 that can tightly engage the surface 26 of the first connector 10 . The surface 81 may be a plane or any other structure, as long as the interaction of the surfaces 26 and 81 can make the first connector 10 and the second connector 70 tightly engage. The surface 81 of the second connecting member 70 may also include elastic or flexible structures to facilitate mutual promotion when the first connecting member 10 and the second connecting member 70 are connected and separated. In a non-limiting example, the second connector 70 may include a male or female threaded luer lock 121 .

As shown in FIG. 12 , a liquid channel 140 is opened in the syringe adapter 2 through the first end 80 and the second end 85 . Syringe adapter 2 is capable of connecting (via luer lock 121 ) a syringe, such as, but not limited to, dispensing medication or withdrawing medication from a bottle (through interaction with a bottle adapter with a connection). Although a luer lock 121 is shown, any other suitable connection may be used. The inhaled medicament can be provided to the patient through interaction with the patient connector 6 having the first connector 10 . The first end 80 of the second connector 70 has a side wall 160 defining an inner cavity 170 containing at least one protrusion 90 therein. The protrusions 90 are dimensioned to interact with the channels 30 of the first connector 10 . Specifically, in a non-limiting example, when the first connector 10 is brought into contact with the second connector 70 through the engagement between the first end 20 of the first connector 10 and the first end 80 of the second connector 70 When engaged, the first end 20 of the first connector 10 and the first end 80 of the second connector 70 mate.

As shown in FIGS. 2-5 and 11 , the second connector 70 will mate with the first connector 10 if the protrusion 90 is aligned with the channel inlet 50 . However, the protrusions 90 may contact the shoulders 40 if the protrusions 90 are not aligned with the channel entrance 50 . In some instances, where the shoulder 40 is preferably rounded or sloped, the shape of the shoulder guides the projection 90 into the channel inlet 50 to engage the first connector 10 and the second connector 70 . The rounded nature of the shoulder 40 enables the engagement of the first connector 10 and the second connector 70 without pre-positioning the components, reducing the difficulty of achieving a fixed connection. It should be understood by those skilled in the art that if the first connecting member 10 has radially outwardly extending protrusions and the second connecting member 70 is provided with a channel on the inner surface, the above principles and the joining process will also work similarly. Accordingly, the description of the drawings and what is described herein should be taken only as exemplary embodiments of the present invention.

With continued reference to FIGS. 2-5 and 11 , when the protrusion 90 is aligned with the channel inlet 50 , the protrusion 90 can enter the channel 30 and effect the engagement of the first connector 10 with the second connector 70 . As the first connector 10 and the second connector 70 are further engaged, the protrusions 90 are further along the channel 30 , through the axial portion 35 . In a non-limiting example, the channel 30 is non-linear, following a path such as, but not limited to, a protrusion 90 on a curved path, allowing one or both of the connectors 10, 70 to rotate relative to the other or to each other.

The non-linear or curved path of the channel 30 brings the protrusion 90 to the transverse portion 60 of the path 30 when the first and/or second link 10, 70 is rotated. Continuing to rotate the first connector 10 and/or the second connector 70 moves the protrusion 90 along the transverse portion 60 of the path 30 and the protrusion 90 approaches the groove 100 . As the first link 10 and/or the second link 70 rotate further, the protrusion 90 reaches the end of the path 30 and cannot rotate further. Release the first connector 10 and/or the second connector 70 so that the protrusion 90 enters the groove 100 . This entry avoids disengagement of the engagement between the first connector 10 and the second connector 70 . The engagement between the protrusions 90 and the grooves 100 may be maintained by any suitable structure, such as, but not limited to, through the use of flexible structures such as, but not limited to, compression coil/coil springs and tension coil/coil springs. Those skilled in the art are familiar with the types of devices that can provide sufficient force or tensile force to retain the protrusions 90 in the grooves 100 to keep the connectors engaged. As described in conjunction with the embodiment shown in FIGS. 7A and 7B , the grooves 110 and 120 are provided with convex parts or structures, which can realize the interference fit between the protrusion 90 and the first connecting piece 10 , so that once the protrusion 90 is Beyond the bulge, the first link 10 will remain connected to the second link 20 until a predetermined amount of rotational force is applied on the links 10 , 70 to cause the protrusion 90 to ride over the bulge again and back via the path 30 . Therefore, the protrusion 90 of the second connector 70 is a clearance fit when entering the groove 100 of the first connector 10 shown in FIG. 2 and requires a biasing force to keep the protrusion 90 in the groove 100, however, The grooves 110, 120 of the first connector 10 shown in Figures 7A and 7B may have a friction fit with the projections 90 so that no biasing force is necessary to maintain the locking fit. However, the grooves 100 shown in Figure 2 and the grooves 110, 120 shown in Figures 7A and 7B, respectively, may be used for a clearance or friction fit with the protrusions 90 with or without biasing forces to maintain a fixed connection.

In some non-limiting examples, the first end 20 of the first connector 10 is a cylinder, the first end 80 of the second connector 70 is a hollow cylinder, and the protrusions 90 face inwardly toward the hollow portion. By inserting the first connecting piece 10 into the hollow portion of the first end 80 of the second connecting piece 70, or alternatively, sliding the hollow portion of the first end 80 of the second connecting piece 70 over the hollow portion of the first connecting piece 10 At the first end 20, the joining of the two connectors 10, 70 can be achieved. Those skilled in the art should understand that in other examples within the scope of the present invention, the protrusions may be provided on the first connecting member 10 and face outward, while the second connecting member 70 has a channel for receiving the protrusions and for Together with the projections, positive locking grooves are formed.

Returning to FIG. 12 , the second connector 70 includes a seal or diaphragm arrangement 150 . The seal or diaphragm arrangement 150 is used to cooperate with a corresponding seal on the first connector 10 to form a sealing interface between the first connector 10 and the second connector 70 as the liquid is transferred. The seal or diaphragm arrangement 150 may also be part of the first connector 10 .

In a non-limiting example, the seal or diaphragm device 150 may be self-healing, and may also be a multi-component seal or diaphragm. For example, in the example shown in FIG. 12 , the sealing device 150 includes a first sealing body 151 , a sealing carrier 152 and a second diaphragm 153 . One end of the sealing carrier 152 is provided with the first sealing body 151 , and the other end is provided with the second sealing body 153 . The first and second sealing bodies 151, 153 define a space 154 therebetween. The second connection also includes a needle 155 in fluid communication with the fluid channel 140 and a bias 157 (eg, a spring) between the luer lock 121 and the sealing device 150 . The seal 150 is used to move between protected and unprotected positions within the housing. As will be described below, when the second link 70 is engaged with the first link 10 , the sealing device 150 moves upwardly within the second link 70 , thereby storing energy (eg, squeezing the offset) in the biasing member 157 . pieces). When the sealing device 150 moves within the second connecting member 70, the needle 155 pierces the sealing body 153 and establishes liquid communication between the first connecting member 10 and the second connecting member 70, so that the first container (eg, a syringe) and the Transfer fluids between second containers (eg, bottles, IV bags, or IV lines). When the second connecting piece 70 is connected with the first connecting piece 10 , the sealing body 153 can cooperate with the corresponding sealing piece provided on the first connecting piece to form a sealed part to prevent liquid from passing through the first and second connecting pieces 10 and 70 Fluid leakage occurred during transfer. In the unconnected state of the second connector 70 , the distal end of the needle 155 is located within the space 154 between the first and second sealing bodies 151 , 153 , keeping the distal end of the needle 155 within the carrier 152 . Other configurations of seals or diaphragm arrangements 150 may also be used in connection with the first and second connectors 10 , 70 .

Those skilled in the art are familiar with seals or diaphragms suitable for use with the embodiments of the invention shown in FIG. 12 and described above, or for a single self-healing seal or diaphragm, which can be A tip (eg, a needle) is pierced, and upon withdrawal of the needle, the seal is largely self-healing, blocking the fluid path. There are many materials suitable for use in seals in the art and should be selected based on the intended use of the device, such as biocompatibility, chemical inertness, and compatibility with any chemical agents or treatments contained therein, through FDA and/or OSHA approved and applicable for CSTD. These seals can be made of natural materials (eg, rubber), synthetic polymers, and/or silicones (eg, room temperature vulcanized silicone).

In any example of the present invention, other water-blocking seals or membranes may also be provided at any preferred location to enhance user safety. For example and without limitation, a material suitable for forming a watertight seal may be provided on the surface 26 of the second end 25 of the first connector 10 , wherein the surface 26 contacts the surface 81 of the first end 80 of the second connector 70 and/or Alternatively, a material suitable for forming a watertight seal is provided on the surface 81 of the first end 80 of the second connector 70 , wherein the surface 81 contacts the surface 26 of the second end 25 of the first connector 10 . As described above, the proximal end of the first end 20 of the first connector 10 may be provided with a sealing body for matching with the sealing body 153 of the second connector 70, so that the first connector 10 and the second connector When the 70 is engaged, a water-tight seal is formed between the two, and any possible leakage due to an accident can be accommodated in the liquid path formed by the liquid passages 130 and 140 .

The interaction between the projections 90 of the second connector 70 and the channels 30 (essentially the grooves 100, 110 and/or 120) of the first connector 10 creates a positive locking, connecting the first connector 10 to the The second connecting member 70 is fixed. Since the protrusion 90 is retained in engagement with the groove 100 by any suitable means, such as, but not limited to, the use of a biasing member 157 (refer to FIG. 12 ), the biasing member 157 may be, for example, but not limited to, a compression coil/coil spring and a tension coil /coil spring, so force other than rotation is required to release positive locking. The other force required to release the positive lock may be to cause the first link 10 and/or the second link 70 to move toward each other, or to pull both apart in the same manner. Thus, in one example, the force of the biasing member 157 must be overcome to separate the first link 10 from the second link 70 . In other words, the biasing force of the biasing member 157 maintains the first and second connecting members 10 , 70 in the locked, connected position by biasing the protrusion 90 within the groove 100 . When the force of the biasing member 157 is overcome, the second connecting member 70 can be rotated and disengaged from the first connecting member 10 . As described above, when the first connector 10 is separated from the second connector 70 , the biasing member 157 transfers the seal carrier 152 back to the position shown in FIG. 12 with the needle 155 in the space 154 . 7A and 7B, the protrusions defined by the grooves 110, 120 achieve an interference fit between the protrusions 90 and the first connector 10, so that once the protrusions 90 are forced over the protrusions, the first The connector 10 will remain connected to the second connector until a predetermined amount of rotational force is applied to the components 10 , 70 to cause the projection 90 to pass the projection again and return via the path 30 . Thus, in conjunction with the example shown in Figures 7A and 7B, the offset 157 is not necessary to achieve positive locking between the components 10, 70, which do not need to be moved axially relative to each other to release the positive locking.

13-17, as described elsewhere herein, connectors 10 and 70 may be used to connect with any suitable medical device (eg, a CSTD). In some non-limiting examples, the connection means may be used with structures or devices used in CSTD systems, such as the patient connector 6 shown in Figures 2-6 and the syringe adapter 2 shown in Figures 8-12. The connection device can also be connected to a bottle adapter (shown in Figures 13-17) for connection to a bottle containing, for example, but not limited to, a lyophilized complex. The bottle adapter 4 can form a water-tight air-tight seal, preventing leakage of potentially toxic compounds. Other structures may also include a syringe adapter to enable compound formulation and transfer of the compounded compound and/or a patient connector to enable infusion of the compound into the patient's circulatory system via an IV line.

As shown in FIG. 13 , a non-limiting example of a first connection member 10 of a connection device to the bottle adapter 4 is provided. The first connector 10 includes a first end 20 and a second end 25 . The first end 20 includes a guide channel 30 having an axial portion 35 and a transverse portion 60 . A groove 100 is opened at the end point of the transverse portion 60 of the channel 30 . It will be understood by those skilled in the art that any type of grooves, such as those designated by 110 and/or 120 in Figures 7A and 7B, may be used within the scope of the present invention. The channel 30 also includes a channel opening 50 that is at least partially defined by a shoulder 40, which in a non-limiting example is circular. The second end 25 of the first connector 10 may also include a bottle connector 190 . The vial connector can be connected to a vial containing the lyophilized compound, and of course, the liquid compound can also be contained in the vial when the liquid compound needs to be safely and reliably transferred to a syringe and/or patient.

In other non-limiting examples, the bottle adapter 4 may include further structures or features to enhance the safety and reliability of dispensing and/or dispensing the compound from the bottle. For example and without limitation, the bottle connector 190 may include an arm 191 for connecting a bottle (not shown). The arms 191 may include curved projections 192 for easy attachment of the bottle. For example, in the example shown in Figures 13-17, the arc 192 of the arms 191 surrounds the neck of the bottle by urging the bottle into the space between the arms 191 or by urging the bottle connector 190 to snap onto the bottle so that the arm 191 surrounds the bottle neck Instead, the bottle is connected to the bottle connector 190 . In some non-limiting examples, the surface 193 can mate with and lock the bottle in place, preventing accidental separation of the bottle from the bottle connector 190 . In a non-limiting example, after the bottle is engaged with the bottle connector 190, the lancet 195 pierces the bottle. Although not shown, a seal or septum may be provided at the proximal end of the first end 20 of the first connector 10 for cooperation with the sealing body 153 of the syringe adapter 2 .

In other non-limiting examples, as shown in FIGS. 13-17 , the bottle adapter 4 may also include a pressure equalizing member 200 . As shown in the figure, the pressure equalizing member 200 may be a pressurized structure, a bellows structure, or any other type of pressure equalizing device well known to those skilled in the art. The pressure equalizer reduces the risk of release of toxic or harmful substances, reduces the possibility of leaks, and reduces the Risk of blowback.

As shown in FIG. 17 , a liquid channel 130 is opened in the bottle adapter 4 for liquid communication with the inside of the bottle (not shown). A ventilation channel 131 is also provided in the bottle adapter 4 to realize the circulation between the bottle and the pressure equalizing member 200 . The ventilation channel 131 enables the pressure equalizer 200 to equalize the pressure in the bottle when engaging, dispensing and suctioning, thereby reducing the risk of back spray.

As shown in Figures 1-6 and 8-19, in some non-limiting examples, the system 1 includes one or more indicators for when the first connector 10 and the second connector 70 are in a locked state (eg, male Provides an indication when lift 90 and grooves 100, 110 and/or 120 form a positive lock). The indicator may be any type of conventional indicator, eg, it may provide an indication of the locked state by visual, tactile or audible means or any combination of these means. For example and without limitation, movement of the protrusion 90 into the grooves 100, 110 and/or 120 may provide an audible and/or tactile indication that a positive lock is established, eg, a click or other similar sound and/or the protrusion 90 interacts with The grooves 100, 110 and/or 120 together enter a positive locking movement.

In other non-limiting examples, the indicators may be visual only, or may be combined visual and tactile or audible. For example and without limitation, one possible indicator shown in the previous figures but explicitly shown in FIG. 19, the visual indicator 165 includes the second end 25 of the first connector 10 and the second connector 70 at the first end of 80. The principle of the indicator 165 is that when the first connector 10 and the second connector 70 are in the locked state, due to the interaction between the protrusion 90 and the groove 100, 110 and/or 120, and the first connector 10 The interaction between the surface 26 of the second connector 70 and the surface 81 of the second connector 70, the external geometry of the second end 25 of the first connector 10 and the first end 80 of the second connector 70 form a visual indication of the locked state. The visual indicator may be a particular geometry and/or alignment of the second end 25 of the first connector 10 with one or more visual indicators provided on the first end 80 of the second connector 70 .

For example and without limitation, with continued reference to FIG. 19 , the indicator 165 may include the common geometry formed by the second end 25 of the first connector 10 and the first end 80 of the second connector 70 . The consistent geometry of the visual indicator 165 indicates the presence of a locked state between the first link 10 and the second link 70 . Additionally, visual indicators may be achieved by the alignment of one or more visual indicators (eg, ribs 161 , 162 and 163 ) on the first connector 10 and the second connector 70 . In addition to providing a visual indicator of the locked state, the ribs 161 , 162 and 163 may also provide support for grasping the first connector 10 and the second connector 70 to connect and disconnect the two.

As shown in FIG. 20 , the syringe adapter 2 provided by an embodiment of the present invention is in a state of being connected or engaged with the patient connector 6 . The interaction between the protrusions 90 and the grooves 100 is shown in dashed lines. This interaction creates a positive locking, and merely rotating one of the first and second connectors 10 and 70 relative to the other is not sufficient to separate the devices. Instead, an axial force (either pressing the first connector 10 and the second connector 70 at the same time, or pulling the two apart) needs to be applied to separate the protrusion 90 and the groove 100 . In addition, the interaction of the first connecting member 10 and the second connecting member 70 squeezes the flexible member 157 in the second connecting member 70 . This squeezing initiates fluid communication between the needle 155 and the fluid path 140 and the fluid passage 130 of the first connector 10 and between the syringe adapter 2 and the patient connector 6, thereby enabling the first Fluid communication is achieved with the second container and/or the intravenous line.

As shown in FIG. 21 , the syringe adapter 2 provided by an embodiment of the present invention is in a connected or engaged state with the bottle adapter 4 . The syringe adapter 2 engages with the bottle adapter 4 to form a positive lock in the same manner as described between the syringe adapter 2 and the patient connector 6 . Syringe adapter 2 and bottle adapter 4 implement the same indicator 165 as described above.

An embodiment of the present invention also provides a method of forming a connection for a medical device or connection device. The method includes providing a first connector 10 having a first end 20 and a second end 25 . The first end 20 includes a channel 30 having a first axial portion 35 . The first end 20 may also include a shoulder 40 at least partially defining the channel inlet 50 . The channel 30 of the first connector 10 may be non-linear and include a transverse portion 60 disposed transversely of the axial portion 35 . The method also includes providing a second connector 70 having a first end 80 and a second end 85 . The first end 80 of the second connector 70 further includes a protrusion 90 for entering the channel 30 of the first connector 10 . The method further includes engaging the first connecting member 10 with the second connecting member 70, of course, those skilled in the art will understand that the second connecting member 70 can also be engaged with the first connecting member 10 within the scope of the present invention .

In some instances, other features of the first and second connectors 10, 70 may also be incorporated into the method of engaging the connectors. For example and without limitation, the transverse portion 60 of the channel 30 may include one or more grooves 100, 110 and/or 120 disposed at its terminus. In this example, the engaging step includes relatively rotating one or both of the connectors 10 , 70 to advance the projection 90 in the channel 30 . Further rotation causes the protrusion 90 to engage with one or more of the grooves 100, 110 and/or 120, creating a locked condition between the connectors of the medical device or connecting device. The formation of the locked state between the connectors 10 and 70 allows the liquid channel 130 in the first connector 10 and the liquid channel 140 in the second connector 70 to form a liquid path through the medical device or connector.

22-25, a second embodiment of a system for liquid containment transfer is shown. The system includes a first connector 2010 to connect with the bottle adapter. The first connector 2010 has a first end 2020 and a second end, which includes a bottle connector 2190 as shown. The first end 2020 may be a three-dimensional structure, and the second end may be any type of structure, such as a bottle connector 2190. The first connector 2010 may be made of any suitable material, such as, but not limited to, plastic and medical grade polymers. These polymers are available under the trademarks of DuPont as well as The product. In a non-limiting example, the second end is a special adapter, the first connector 2010 can be made of any suitable material, wherein the first end 2020 is made of plastic or medical grade polymer or other suitable material production.

With further reference to Figures 22-25, in a non-limiting example of the present invention, the first connector 2010 further includes at least one channel 2030 extending from a portion of the first end 2020 remote from the second end to the first end 2020 near the second end end part. The channel 2030 is used in the process of engaging the first connector 2010 with the second connector 2070, and the channel 2030 may follow any useful path. In contrast to the non-limiting examples shown in FIGS. 2-5 , the example of the first connector 2010 shown in FIGS. 22-25 includes a channel with a smaller arc and a more straight line in the axial direction.

The channel 2030 may have several separate sections, including a channel inlet 2050, an axial or substantially axial section extending along the length of the first end 2020 of the first connector 2010, and a laterally extending axial section near the first end 2020 of the first connector 2010. Transverse portion 2060 at both ends. The first end 2020 of the first connector 2010 , in addition to the channel inlet 2050 , also includes a shoulder 2040 that defines the channel inlet 2050 . In a non-limiting example, such as those shown in Figures 2-5, the shoulders 2040 are not rounded. Rather, the shoulder 2040 is more angular and still defines and guides the projection of the second link into the channel entry 2050 . The shoulder 2040 enables the engagement of the first connector 2010 and the second connector 2070 without any pre-positioning of the components, reducing the difficulty of achieving a fixed connection. The channel 2030 may also define a groove 2100 for receiving a portion of the second connector 2070 .

Returning to Figures 23 and 24, there is shown a front view and a schematic structural diagram of a first connector 2010 provided in a non-limiting embodiment of the present invention engaged with a second connector 2070 as a syringe adapter. The engagement of the first connecting piece 2010 and the second connecting piece 2070 makes a liquid channel formed between the two, and realizes the preparation, absorption and transfer of the compound. Apart from the shape of the channel 2030 and shoulder 2040 of the first connector 2010, the connected elements are substantially the same as those previously described, including the connection of the surfaces 2026 and 2081 of the first and second connectors 2010 and 2070, respectively. In other examples, the arm 2191 of the bottle connector 2190 can surround the bottle and cause the needle 2195 to pierce the bottle, thereby delivering and/or aspirating the liquid.

Returning to FIG. 25 , a cross-sectional view of the first connector 2010 and the second connector 2070 is shown when engaged. The second connector 2070 has first and second ends, a side wall 2160 that defines the hollow 2170, and a protrusion for mating with the first connector 2010. In the non-limiting example shown in Figure 25, the second connector 2070 includes a syringe adapter at the second end. The syringe adapter includes a luer lock 2121 for mating with any type of syringe. Those skilled in the art will understand that a luer lock can be used to mate the syringe adapter with any type of syringe with a luer lock. As shown in Figure 25, the syringe adapter includes a male luer lock 2121 that can mate with any type of female luer lock (not shown).

The second connector 2070 includes a fluid channel 2140, and in a non-limiting example, the second connector 2070 also includes a seal or membrane device 2150. A seal or diaphragm arrangement 2150 is used to form a watertight seal within the liquid channel 2140. The seal or diaphragm device 2150 may only form a watertight seal in the second connector 2070, and the seal or diaphragm device 2150 may also be in the first connector 2010 when the second connector 2070 is engaged with the first connector 2010. A seal is formed within the liquid channel 2140 and the liquid channel 2130 . The seal or diaphragm arrangement 2150 may also be part of the first connector 2010.

In a non-limiting example, the seal or septum device 2150 may be self-healing, such as when the second connector 2070 has a needle 2155, the second connector 2070 includes a syringe adapter, and the first connector 2010 includes a bottle connector At 2190, the user or medical staff dispensing the compound in the vial operates the syringe and the needle pierces the seal 2150. When the compound is formulated and the drug is drawn into the syringe, the result of this process is that the syringe is withdrawn through the seal or septum device 2150, repairing the watertight seal and preventing the compound from contacting the user or healthcare provider.

In a non-limiting example, the seal or diaphragm device 2150 may also be a multi-component seal or diaphragm. For example, in the example shown in FIG. 25 , the seal 2150 consists of three separate parts 2151 , 2152 and 2153 . The sealing body 2151 portion may be a flexible, self-healing septum in which the needle 2155 is placed. The compliant nature of the seal creates a watertight seal between the cavity 2154 through the primary seal body 2152 and the cavity containing the majority of the needle 2155. The sealing body 2153 is also partially self-healing, keeping the cavity 2154 isolated from the liquid channel 2140. The user or medical staff dispensing the compound in the vial operates the syringe and the needle pierces the seal 2153. When the compound is formulated and the drug is drawn into the syringe, the result of this process is that the syringe is withdrawn through the seal or septum 2153 and into the cavity 2154, repairing the watertight seal and preventing the compound from contacting the user or healthcare provider. Keeping the syringe between the two water-tight seals 2151, 2153 provides further protection for the user.

Those skilled in the art are familiar with seals or membranes suitable for use with the embodiments of the invention shown in FIG. 25 and described above, or for a single self-healing seal or membrane, which can be A tip (eg, a needle) is pierced, and after the needle is withdrawn, the seal is essentially self-healing, thereby blocking the fluid path. There are many materials suitable for use in seals in the art and should be selected based on the intended use of the device, such as biocompatibility, chemical inertness, and compatibility with any chemical agents or treatments contained therein, through FDA and/or OSHA approved and applicable for CSTD. These seals can be made of natural materials (eg, rubber), synthetic polymers, and/or silicones (eg, room temperature vulcanized silicone).

As shown in Figures 26A-26E, other examples of projections 90 of the second connector 70 are provided. Although the protrusions 90 shown in FIGS. 1-25 are basically circular or hemispherical, the protrusions 90 may also have any other suitable shape as long as they can enter the channel 30 of the first connector 10 . Specifically, as shown in FIGS. 26A-26E, the protrusions 90 may be circular, rectangular, diamond-shaped, square or rectangular. Any of these shapes may be used to fit the channels 30 and grooves 100 shown in Figure 2 or the channels 30 and grooves 110, 120 shown in Figures 7A and 7B, wherein the protrusions 90 are in the grooves 100, 110, 120 medium clearance or friction fit. The square and rectangular projections 90 are particularly suitable for clearance fits, ensuring a secure fit in the grooves 100 , 110 , 120 .

Although the present invention has been described using some unique embodiments of a connection device for a CSTD and method of use thereof, modifications and substitutions of the present invention may be made by those skilled in the art within the spirit and scope of the present invention. Therefore, the above specific embodiments are provided for the purpose of illustration only, and not for the purpose of limitation.

Claims (19)

1. a kind of attachment device for Medical Devices, comprising:

The first connector having a first end and a second end, first connector offer at least one at the first end A channel, at least one described channel have axially extending first, the second of the axial transverse direction extension Portion and the third portion extended at described first and between second described, second restriction at least one channel One terminal, at least one described channel have shoulder, the shoulder at the first end close to first connector Define that feeder connection, first connector have described first and the third portion for limiting at least one channel Part curved wall, the curved wall from the feeder connection at least one channel it is described second bending；With And

The second connector having a first end and a second end, second connector are provided at least one close to the first end Protrusion；

Wherein described in second connector at least one to protrude out into described in first connector at least one logical When road, the axial movement of second connector towards first connector connects at least one protrusion with the curved wall Close, and at least one of first connector and second connector relative to another connector rotate, with into Enter the lock state that at least one protrusion reaches second terminal at least one channel, wherein the shoulder will be for will be described At least one described protrusion of second connector imports described feeder connection, without consider at least one described protrusion relative to The positioning of the feeder connection.

2. attachment device as described in claim 1, wherein described first of the feeder connection than at least one channel Portion and at least one channel it is described second wide.

3. attachment device as described in claim 1, wherein described second of at least one channel includes axially extending Groove.

4. attachment device as claimed in claim 3, wherein the first end of the groove towards first connector is prolonged It stretches.

5. attachment device as claimed in claim 3, wherein the groove relative at least one channel described second The second end of portion towards first connector extends.

6. attachment device as claimed in claim 3, wherein when first connector and the second connector are in the lock state When, at least one described protrusion and the groove form positive locking, can by first connector and second connector Removably fix.

7. attachment device as described in claim 1, wherein described second of at least one channel includes relative to institute The first end of the first connector is stated to the substantially axial groove of distal end extension and relative to the institute of first connector State the substantially axial groove that first end proximally extends.

8. attachment device as described in claim 1, wherein first connector and second connector further include running through Fluid passage therein, when first connector and second connector engage, the fluid passage forms liquid Path.

9. attachment device as claimed in claim 8, wherein first connector and second connector are at least within One further includes the self-repairing control in respective fluid passage, and wherein, when first connector is connect with described second When part engages, the self-repairing control forms water proof sealing.

10. attachment device as described in claim 1 further includes indicator, it is used to indicate first connector and described the Lock state between two connectors.

11. attachment device as claimed in claim 10, wherein the indicator is visual detector.

12. attachment device as claimed in claim 11, wherein first connector and second connector respectively include Planar portions and arcus part, the visual detector includes the planar portions of the first connector and the planar portions of the second connector be aligned with And first the arcus part of connector be aligned with the arcus part of the second connector.

13. attachment device as claimed in claim 10, wherein the indicator is tactile indicators, and wherein, it is described at least The interaction of one protrusion and groove provides the tactile instruction of lock state.

14. attachment device as described in claim 1, wherein the first end of second connector includes that encirclement is hollow The direction of the side wall in portion, the side wall towards the second end far from second connector is axially extending, and the wherein side wall packet At least one described protrusion is included, at least one described protrusion extends internally.

15. attachment device as described in claim 1, wherein wherein the one of first connector and second connector A to be arranged on syringe adapter, at least one of which of bottle adapter and patient's connector is arranged in another connector On.

16. attachment device as described in claim 1, wherein the shoulder be it is circular, at least one channel it is described First defines non-directional path with the third portion.

17. a kind of attachment device for Medical Devices, comprising:

The first connector having a first end and a second end, first connector offer at least one at the first end A channel, at least one described channel, which has from the position of the first end close to first connector to described first, to be connected The second end of fitting extend first, from second, the Yi Ji extended relative to first transverse direction Described first and it is second described between the third portion that extends, at least one described channel is close to first connector There is shoulder, the shoulder defines feeder connection, and first connector, which has, limits described at least one at the first end The first wall of described first of a channel and the part in the third portion, first wall are non-linear on the first connector Second extension of the path from the first end of first connector at least one channel, the first connector have the Two walls, second wall is along the nonlinear path on connector from the first end of the first connector at least one channel Third portion extends and second extension along the nonlinear path on the first connector from third portion at least one channel；With And

The second connector having a first end and a second end, second connector are provided at least one close to the first end Protrusion；

Wherein at least one described convex configuration of second connector be received in first connector it is described at least There is first connector to fix with second connector for one channel, first connector and second connector Lock state, when first connector and second connector are in the lock state, the institute of second connector In described second for stating at least one channel that at least one protrusion is located at first connector, and it is wherein described logical Described first of at least one channel of first connector described in road inlet ratio is wide.

18. attachment device as claimed in claim 17, wherein at least one channel of first connector it is described Second extends in the transverse direction of the longitudinal axis relative to first connector.

19. attachment device as claimed in claim 17, wherein described second of at least one channel includes axial prolong The groove stretched.